Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.
This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women aged from 18-45 with histopathologically confirmed CIN2 | In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow up | Other | Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical histopathology testing at baseline | Cervical histopathology was performed at baseline for all participants. | Baseline |
| Cervical histopathology testing at 6-month follow-up | Cervical histopathology was performed at 6-month follow-up for all participants. | 6-month follow-up |
| Cervical histopathology testing at 12-month follow-up | Cervical histopathology was performed at 12-month follow-up for all participants. | 12-month follow-up |
| Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | Baseline |
| Human Papillomavirus (HPV) viral integration test at 6-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants. | 6-month follow-up |
| Human Papillomavirus (HPV) viral integration test at 12-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants. | 12-month follow-up |
| Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
≤45 years old Chinese women with cervical histopathology for CIN2.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binhua Dong | Contact | +86-591-87558732 | dbh18-jy@126.com | |
| Pengming Sun | Contact | +86-591-87558732 | sunfemy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pengming Sun | Fujian Maternal and Child Health Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Maternity and Child Health Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40295124 | Derived | Zhang Y, Zhang Y, Hu T, Pu X, Dong B, Tuo X, Zou H, Zhang W, Lyu Q, Huang W, Xue H, Xu S, Osafo KS, Ren Y, Lin W, Su J, Huang X, Sun P. Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study. BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Samples from cervix and vagina containing related cells, tissues and secretions.
|
| Cervical cytology testing at 3-month follow-up | All participants were tested for cervical cytology at 3-month follow-up. | 3-month follow-up |
| Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up | 6-month follow-up |
| Cervical cytology testing at 9-month follow-up | All participants were tested for cervical cytology at 9-month follow-up | 9-month follow-up |
| Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up |
| 16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline |
| 16SrRNA sequencing of the vaginal secretions at 3-month follow-up | All participants underwent vaginal secretion sequencing at 3-month follow-up. | 3-month follow-up |
| 16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up |
| 16SrRNA sequencing of the vaginal secretions at 9-month follow-up | All participants underwent vaginal secretion sequencing at 9-month follow-up | 9-month follow-up |
| 16SrRNA sequencing of the vaginal secretions at 12-month follow-up | All participants underwent vaginal secretion sequencing at 12-month follow-up | 12-month follow-up |
| Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline |
| Human Papillomavirus (HPV) genotyping tests at 3-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up. | 3-month follow-up |
| Human Papillomavirus (HPV) genotyping tests at 9-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up. | 9-month follow-up |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
|
| Longyan First Hospital | Recruiting | Longyan | Fujian | China |
|
| The Second Hospital of Longyan | Recruiting | Longyan | Fujian | China |
|
| Ningde Municipal Hospital of Ningde Normal University | Recruiting | Ningde | Fujian | 352100 | China |
|
| The First Hospital of Putian City | Recruiting | Putian | Fujian | 351100 | China |
|
| The Affiliated Hospital of Putian University | Recruiting | Putian | Fujian | China |
|
| Sanming Second Hospital | Recruiting | Sanming | Fujian | China |
|
| Zhangzhou affiliated Hospital of Fujian Medical University | Recruiting | Zhangzhou | Fujian | 363000 | China |
|
| Gansu Provincial Maternal and Child Health Care Hospital | Recruiting | Lanzhou | Gansu | China |
|
| Shenzhen Maternity and Child HealthCare Hospital | Recruiting | Shenzhen | Guangdong | China |
|
| Guiyang maternal and child health care hospital | Recruiting | Guiyang | Guizhou | China |
|
| Hubei Maternal and Child Health Care Hospital | Recruiting | Wuhan | Hubei | China |
|
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Recruiting | Wuhan | Hubei | China |
|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
|
| Jiangxi maternal and Child Health Hospital | Recruiting | Nanchang | Jiangxi | China |
|
| Shanghai First Maternity and Infant Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Northwest Women's and Children's Hospital | Recruiting | Xi’an | Shanxi | China |
|
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
|
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065308 | Morphological and Microscopic Findings |
Not provided
Not provided